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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03746574
Other study ID # 15-132
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2016

Study information

Verified date November 2018
Source Providence Health & Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To demonstrate that a multimodal intervention can reduce burnout in a multidisciplinary primary care practice while improving other components of the Quadruple Aim including staff engagement, patient experience, productivity and quality.


Description:

Recruitment

This was a randomized trial of eleven internal medicine and family medicine clinics of Providence Medical Group (PMG) in Portland Oregon. All of the clinics were non-residency clinics. The study was conducted between January 2015 and January 2016. Introductory meetings were held with leadership dyads (medical director and manager) of all 23 clinics in the Portland area to overview the curriculum and outline conditions of study participation. Expectations included: holding the curriculum sessions during usual work hours, endorsement of participation by clinic staff, and that specific individuals would be identified to facilitate sessions for the clinic. Leadership of each clinic, subsequently, discussed the curriculum with the staffs of the clinics and eleven committed to participate and were then randomized. The staffs of the intervention clinics then received the twelve session Strengthening Compassion curriculum. Four of the intervention clinics held the sessions at the beginning of the day and opened clinic 80 minutes late. One clinic held the sessions during an extended lunch hour.

Randomization and Follow-up

Eleven clinics volunteered to participate. (47.8% of eligible clinics) Five clinics were randomly selected to participate in the Strengthening Compassion curriculum and six were selected as controls.

341 individuals participated in the study, including providers, clinical, and administrative staff. The baseline survey was completed by 153 participants in the intervention clinics and 188 participants in the control clinics. 244 of the initial participants completed a survey at the end of the intervention period and 191 at 6 month follow up Participants in the intervention clinics engaged in a 12 session curriculum offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided.

Each session was facilitated by internal non-physician staff (e.g. social workers, medical assistants, nurses) recruited by clinic leadership. The facilitators received two hours of on-line training in group facilitation, mindfulness meditation, content/exercises for each session, and were provided with a detailed facilitators guide. The facilitators also received one half hour of additional training before each session via networked phone calls and were supported by on-line materials.

Study Outcomes

Outcomes were measured utilizing a fifty one question survey administered at baseline, at the end of the 6-month curriculum and at 6 months follow-up. This survey was a composite of validated surveys that measure compassion, mindfulness, burnout, clinic relations, job satisfaction, and clinical satisfaction. The Compassion component of the survey used the Santa Clara Brief Compassion Scale (SCBCS). Mindfulness was measured with the Mindful Attention Awareness Scale (MAAS). Burnout was measured with the Maslach Burnout Inventory-Human Services Survey for Medical Personnel (MBI-HSS (MP)) comprised of three sub-scales that measure emotional exhaustion, depersonalization, and personal accomplishment. Questions about caregiver roles in the clinic, clinic relations, job satisfaction, clinical satisfaction, time working in the clinic, and time working in healthcare, were derived from a previously utilized survey provided by the Center for Outcomes Research and Education of the Providence Health and Services. Data on caregiver engagement was collected in October 2015 and October 2016 via organization wide survey through Willis-Tower-Watson. Engagement and disengagement are pre-defined categories on the Willis-Tower Watson survey. Patient experience data was collected by Press Ganey as part of their standard survey process. Impact on productivity and quality were assessed from data, routinely collected, in the Providence St. Joseph Health administrative data base.


Recruitment information / eligibility

Status Completed
Enrollment 341
Est. completion date December 31, 2016
Est. primary completion date July 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All employees working in selected clinics

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Compassion Curriculum
12 session curriculum offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Providence Health & Services

References & Publications (7)

Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6. doi: 10.1370/afm.1713. — View Citation

Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review. PLoS One. 2016 Jul 8;11(7):e0159015. doi: 10.1371/journal.pone.0159015. eCollection 2016. Review. — View Citation

Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-Graham C, Peters D, Hodkinson A, Riley R, Esmail A. Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Oct 1;178(10):1317-1330. doi: 10.1001/jamainternmed.2018.3713. — View Citation

Panagioti M, Panagopoulou E, Bower P, Lewith G, Kontopantelis E, Chew-Graham C, Dawson S, van Marwijk H, Geraghty K, Esmail A. Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Feb 1;177(2):195-205. doi: 10.1001/jamainternmed.2016.7674. Review. — View Citation

Salyers MP, Bonfils KA, Luther L, Firmin RL, White DA, Adams EL, Rollins AL. The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis. J Gen Intern Med. 2017 Apr;32(4):475-482. doi: 10.1007/s11606-016-3886-9. Epub 2016 Oct 26. — View Citation

West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28. Review. — View Citation

West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Burnout Score on Maslach Burnout Inventory Score on Maslach Burnout Inventory: Maslach Burnout Inventory - Human Services Survey (MBI-HSS) is a 22-item survey that covers 3 areas: Emotional exhaustion (EE), Depersonalization (DP), and Low sense of personal accomplishment (PA). There are multiple questions for each of these subscales and responses are in the form of a frequency rating scale (never, a few times a year or less, once a month or less, a few times a month, once a week, a few times a week, every day). Baseline, 6 Months and 12 Months
Primary Change in Compassion: Score on Santa Clara Brief Compassion Scale Score on Santa Clara Brief Compassion Scale: The Santa Clare Brief Compassion Scale is a brief index that assesses compassion and its link to prosocial behaviors. An example from a 'compassion for humanity' item include ""When I hear about someone (a stranger) going through a difficult time, I feel a great deal of compassion for him or her." Responses are given on a 7-point scale from "Not at all true for me" to "Very true for me." Baseline, 6 Months and 12 Months
Primary Change in Mindfulness: Mindful Attention Awareness Score Mindful Attention Awareness Score: The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Scored on a scale 1=almost never--> 6=almost always Baseline, 6 Months and 12 Months
Primary Change in Intent to stay on Caregiver survey Intent to stay on Caregiver survey Baseline and 12 months
Secondary Change inCaregiver Engagement measured on annual Willis Tower Watson Survey Caregiver Engagement measured on annual Willis Tower Watson Survey Baseline and 12 months
Secondary Change in Patient Experience on routine Press Ganey Survey Patient Experience on routine Press Ganey Survey Baseline, 6 Months and 12 Months
Secondary Change in Visit per month Average number of visits Baseline, 6 Months and 12 Months
Secondary Change in Panel Size Panel Size per FTE Baseline, 6 Months and 12 Months
Secondary Change in Diabetes Control HbA1c Baseline, 6 Months and 12 Months
Secondary Change in BP control % people with blood pressure <140/80 Baseline, 6 Months and 12 Months
Secondary Change in Cancer Screening Rate Average of rates of screening for breast, colon, and cervical cancer Baseline, 6 Months and 12 Months
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